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Completed

NCT Number: NCT02428634

The Program SI! for Cardiovascular Health Promotion at Elementary School

The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation for Science, Health and Education

Madrid, 28001, Spain

About this study

The Program SI! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). Since the Program SI! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the Program SI! for Elementary addressed to children from 6 to 11 years. The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). In the Community of Madrid-South Area (Spain), 48 public schools from were randomly assigned to Program SI! for Elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). The Program SI! for Elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. Besides, as some schools involved in the preschool study continues the Program SI! for Elementary, the investigators can be able to evaluate the impact of the Program SI! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children from public schools with canteen services located in the South Madrid Area of Education, having from 1st to 6th grades and at least two classrooms in 1st grade.

Exclusion criteria

  • The coordination team of the SHE Foundation establishes the adherence criteria and the schools not reaching the minimum considered can be excluded. Questionnaires scoring from students with special educational needs will be excluded from the analysis of questionnaires, as well as repeat students.

Treatment and study plan

PSIE13

Behavioral

The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year.

PSIE46

Behavioral

The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year.

Primary outcomes

  1. Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children.

    Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for children

    To evaluate children's lifestyle we use a specific questionnaire about knowledge, attitudes and habits in relation to the four components of Program SI! for Elementary (diet, physical activity, body and heart, and emotions management) (article under revision). A trained team of psychologist applies the children's questionnaires at the school.

  2. Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention.

    Time frame: 3-year, and 6-year changes from baseline on cardiovascular health markers of children

    To evaluate the impact of the Program SI! for Elementary in cardiovascular health markers of children blood pressure and some anthropometric parameters are measured (height, weight, waist circumference and triceps and subscapular skinfold thickness) under standardized protocol developed in previous studies (Santos-Beneit et al. 2014).

Secondary outcomes

  1. Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.

    Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for families

    The family's habits are evaluated through a specific questionnaire related to key messages for families provided by the Program SI! for Elementary and some general questions about tobacco use and health status (article under revision) and stress perception (Remor 2006). Also in the questionnaire for families are included some questions about their son or daughter's habits (Serra-Majem et al 2004, Goodman 1997, Encuesta Nacional de Salud 2011/2012).

  2. Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers

    Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers

    The lifestyle of the teachers is evaluated measuring adherence to the Mediterranean lifestyle (Sotos-Prieto et al. 2014) and questions about stress perception (Remor 2006).

  3. Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment

    Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment

    The school environment is evaluated through questions related to the recommendations provided in the Program SI! for Elementary intervention as avoid eating commercially prepared baked foods at school.

Sponsors and collaborators

Lead sponsor

Foundation for Science, Health and Education, Spain

Other

Collaborators

  • Fondation Daniel & Nina Carasso

Registry information

Official study title

The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial

Acronym: PSIE

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2015
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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